UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004788 |
|---|---|
| Receipt number | R000005663 |
| Scientific Title | Immunogenicity and cross-immunity after booster immunization with adjuvanted whole virion A (H5N1) vaccine of Qinghai strain Part2 Immunization effect on adults who might be exposed to H5N1 viral components |
| Date of disclosure of the study information | 2010/12/24 |
| Last modified on | 2013/11/22 16:46:00 |
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Basic information
Public title
Immunogenicity and cross-immunity after booster immunization with adjuvanted whole virion A (H5N1) vaccine of Qinghai strain Part2 Immunization effect on adults who might be exposed to H5N1 viral components
Acronym
A non-blind phase 4 clinical trial with adjuvanted whole virion A (H5N1) vaccine of Qinghai strain Part2 Immunization effect on adults who might be exposed to H5N1 viral components
(H5N1_QB2)
Scientific Title
Immunogenicity and cross-immunity after booster immunization with adjuvanted whole virion A (H5N1) vaccine of Qinghai strain Part2 Immunization effect on adults who might be exposed to H5N1 viral components
Scientific Title:Acronym
A non-blind phase 4 clinical trial with adjuvanted whole virion A (H5N1) vaccine of Qinghai strain Part2 Immunization effect on adults who might be exposed to H5N1 viral components
(H5N1_QB2)
Region
| Japan |
Condition
Condition
Prevention of influenza
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of immunogenicity and safety of immunization to the individuals who have participated in manufacturing vaccine and potentially exposed to virus components
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of neutralizing antibody to Qinghai strain, if possible Vietnam, Indonesia and Anhui strain
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Individuals, who have participated in manufacturing influenza A (H5N1) vaccine in the institutes according to the 2010 MHLW contract
2)Individuals, who could be followed under the regulation of the clinical trial, could be examined according to the protocol, and could report their symptoms.
Key exclusion criteria
1) Individuals with the history of Swine Influenza A (H5N1) virus infection. (obtained by subjects)
2) Individuals, who had history of anaphylaxis to foods or medicines previously.
3) Individuals with severe diseases in cardiovascular, blood, respiratory, liver, kidney, digestive or neurological systems in their clinical recording.
4) Individuals with a history of acute disseminated encephalomyelitis and Guillain-Barre syndrome in the past.
5) Individuals participated in a clinical trial with influenza vaccine within four months (counted from the date of vaccination).
6) Individuals vaccinated with live vaccine within 27 days, or received a dose of inactivated vaccine within six days (counting from the date of vaccination).
7) Individuals received with gamma globulin or blood transfusion within three months, or received the formulation of high dose of gamma globulin therapy (200 mg / kg or more) within six months (counting from the date of vaccination).
8)Individuals who are deemed to be inappropriate by the investigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Ihara |
Organization
National Hospital Organization Mie National Hospital
Division name
Director
Zip code
Address
357 Ozato-Kubota, Tsu, Mie
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Clinical Research Center, National Hospital Organization
Division name
Clinical trial promotion office,
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Clinical Research Center,
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 09 | Month | 01 | Day |
Other
Other related information
prospective observational study
Management information
Registered date
| 2010 | Year | 12 | Month | 24 | Day |
Last modified on
| 2013 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005663
